The invention relates to a system and method for testing chromatography media and devices, particularly chromatography devices including membranes and monoliths. More particularly, the invention relates to testing the integrity and/or chromatography type of chromatography membranes and monoliths sealed in a housing.
Chromatography devices including beads in the form of columns or packed beds can be integrity tested by, for example, using the height equivalent to a theoretical plate (HETP) method. The HETP method involves introducing an analyte into the column under non-binding conditions, washing the analyte through the column, and detecting the analyte in the column effluent. The HETP is then calculated using known mathematical equations. The HETP measurement demonstrates bed integrity (packing), and can provide an indication as to bed to bed reproducibility.
However, the HETP method does not show the sealing integrity of a sealed unit, e.g., a capsule, or a housing (that can be re-usable) including chromatography media sealed therein, or a monolith containing a polymerized gel or inorganic material (e.g., a silica-based material) sealed therein. Moreover, while the chromatography type of the beads in a column can be determined relatively easily, e.g., by analyzing a few beads, there is an unmet need in the art for a method for determining the chromatography type of the chromatography membranes or monoliths sealed in a housing, e.g., a chromatography capsule.
The present invention provides for ameliorating at least some of the disadvantages of the prior art. These and other advantages of the present invention will be apparent from the description as set forth below.